Data Integrity Specialist

2 days ago

Hyderabad Secunderabad Telangana, India beBeeDataIntegrity Full time ₹ 8,00,000 - ₹ 12,00,000
Job Description

We are seeking a highly skilled Data Integrity Specialist to join our team. The ideal candidate will be responsible for ensuring all computerized systems meet the required guidelines and regulations.

Key Responsibilities
  • Ensure all computerized systems comply with 21 CFR Part 11, EU Annex 11, and GAMP5 guidelines.
  • Perform and review computerized system validation life cycle deliverables.
  • Implement and maintain data integrity at site as the Data Integrity Compliance Officer (DICO).
  • Develop and execute a regimen of data integrity checks on shopfloor and update the Data Integrity Risk Assessment (DIRA).
  • Handle and ensure compliance of SOPs related to data integrity IT systems.
  • Conduct investigations related to data integrity, computerized systems, and engineering department as applicable.
  • Collaborate with stakeholders on data integrity and IT-systems projects.
  • Participate in internal data integrity audits and ensure compliance.
  • Select and train Data Integrity champions.
  • Review change controls, deviations, CAPA, and other QMS tools.
  • Review periodic review reports.
  • Assess suppliers for computerized systems, instruments, and equipment.
  • Approve schedules for data backup restoration, time synchronization, etc.
  • Review audit trail reports for computerized systems, including HMI, SCADA, DCS, etc.
  • Ensure user management activities for computerized systems are compliant.
  • Prepare and review quality risk assessments, including part 11 compliance and data integrity.
  • Review qualification documents for manufacturing equipment, facility, utilities, and associated ancillary systems.
  • Verify CAPA effectiveness.
  • Ensure GMP compliance for manufacturing equipment areas, utilities, and testing instruments.
  • Review software application qualifications.
  • Comply with SHE guidelines, rules, and regulations.
  • Identify and address unsafe acts and conditions immediately.
  • Report incidents, accidents, near misses, and illnesses to superiors.

This is an exciting opportunity to work in a dynamic environment and make a significant impact on data integrity.

Requirements
  • Strong understanding of data integrity principles and regulations.
  • Excellent communication and interpersonal skills.
  • Able to work independently and collaboratively as part of a team.
  • Highly organized and detail-oriented with strong problem-solving skills.
  • Proficient in relevant software applications and systems.
What We Offer

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

About Us

We are a forward-thinking organization committed to excellence in data integrity and regulatory compliance.

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